Role DescriptionYou are a technical writer working within the site Data Integrity project for process automation systems. You implement changes to system documentation following the analysis of data integrity gap assessments, including security, periodic review SOP’s, system design etc…. You execute and report periodic reviews of process automation and IT systems according to predefined processes. Is competent in the use of an electronic documentation management systems (EDMS). You work with the DI SME to offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners.

The focus of the function is to execute remediation actions that ensure that the Computerized Quality Systems meet the current requirements of Data Integrity.

The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions.

Responsibilities• Write and revise site & system SOP’s etc… to include data integrity requirements • Analyse data integrity gap analysis results, propose and execute remediation actions • Guides Business and Technical System Owners in current expectation of Data Integrity • Understands both technical and procedural requirements of Data Integrity • Familiar with production systems: PLC / HMI / SCADA / MES & standalone systems such as filter integrity testers • Manages work according to a schedule

RequirementsMinimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life. • Pharmaceutical or related industry work experience for 2-4 years, of which a substantial part in Computerized Systems and related functions.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.